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Type(s) of Cancer
Leukemia/Lymphoma
Study Phase
Phase 3
Study Completion Date
2018-08-07
NCT01886872Uploaded 02-09-2020
Access via NCI by Request
PDS UID: nci-data-400
A Randomized Phase III Study of Bendamustine Plus Rituximab Versus Ibrutinib Plus Rituximab Versus Ibrutinib Alone in Untreated Older Patients (>/= 65 Years of Age) With Chronic Lymphocytic Leukemia (CLL)
Provider Information
Provider Data DescriptionDataset NCT01886872-D5-Dataset.csv (bsl_qol) is one of 5 datasets associated with PubMed ID 30501481. This dataset contains information that will allow you to reproduce the baseline QOL analysis (table S3) in the supplemental materials.
SponsorNational Cancer Institute (NCI)
Data ProviderNational Cancer Institute
Clinical Trials.gov Information
Brief SummaryThis randomized phase III trial studies rituximab with bendamustine hydrochloride or ibrutinib to see how well they work compared to ibrutinib alone in treating older patients with previously untreated chronic lymphocytic leukemia. Monoclonal antibodies, such as rituximab, may block cancer growth in different ways by targeting certain cells. Drugs used in chemotherapy, such as bendamustine hydrochloride, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Ibrutinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. It is not yet known whether rituximab with bendamustine hydrochloride may work better than rituximab and ibrutinib or ibrutinib alone in treating chronic lymphocytic leukemia.
ConditionsStage I Chronic Lymphocytic Leukemia
Stage II Chronic Lymphocytic Leukemia
Stage III Chronic Lymphocytic Leukemia
Stage IV Chronic Lymphocytic Leukemia
Intervention TypeDrug: Bendamustine Hydrochloride
Drug: Ibrutinib
Other: Laboratory Biomarker Analysis
Other: Quality-of-Life Assessment
Biological: Rituximab
Drug(s)Drug: Bendamustine Hydrochloride
Drug: Ibrutinib
Total Enrolled547
RandomizationRandomized
Blinding MethodNone
Arms InterventionArm I (rituximab, bendamustine hydrochloride) - Active Comparator
Arm II (ibrutinib) - Experimental
Arm III (ibrutinib, rituximab) - Experimental
Secondary IDNCI-2013-01220
PubMed (PMID)34274940
30501481
Collaborator(s)N/A
Region(s)United States
Canada
Age Range65 Years and older (OLDER_ADULT)
Files: NCT01886872-D5
Data DictionaryNCT01886872-D5-Data-Dictionary_0.pdf
DATANCT01886872-D5-Dataset_0.csv
OTHERREADME.pdf
Files: NCT01886872-D4
Data DictionaryNCT01886872-D4-Data-Dictionary_0.pdf
DATANCT01886872-D4-Dataset_0.csv
OTHERREADME.pdf
Files: NCT01886872-D3
Data DictionaryNCT01886872-D3-Data-Dictionary_0.pdf
DATANCT01886872-D3-Dataset_0.csv
OTHERREADME.pdf
Files: NCT01886872-D2
Data DictionaryNCT01886872-D2-Data-Dictionary_0.pdf
DATANCT01886872-D2-Dataset_0.csv
OTHERREADME.pdf
Files: NCT01886872-D1
Data DictionaryNCT01886872-D1-Data-Dictionary_0.pdf
DATANCT01886872-D1-Dataset_0.csv
OTHERREADME.pdf
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